Clinical trial · Interventional
Clinical Study of the Mirabilis High-Intensity Focused Ultrasound System for Non-Invasive Treatment of Uterine Fibroids
Clinical Study of a Focused Ultrasound Device for Treating Uterine Fibroids and Menorrhagia
NCT01946178CI-TRIAL-00027816completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The Mirabilis High-Intensity Focused Ultrasound (HIFU) Treatment System delivers therapeutic focused ultrasound energy to the uterus under integrated ultrasound imaging guidance to offer non-invasive treatment for uterine fibroids. The purpose of this clinical study is to assess the initial safety and performance of the Mirabilis HIFU Treatment System for transabdominal treatment of uterine fibroids in eligible women who are scheduled to undergo hysterectomy following treatment with the device or who are seeking relief from fibroid-related symptoms.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Fibroids (Leiomyomas) | Uterine Corpus Leiomyoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mirabilis High-Intensity Focused Ultrasound Treatment System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Focused ultrasound treatment
- description
- Patients in this arm will receive fibroid treatment using the Mirabilis High-Intensity Focused Ultrasound Treatment System.
- interventionNames
- Device: Mirabilis High-Intensity Focused Ultrasound Treatment System
Primary outcomes (1)
- measure
- Evaluation of All Adverse Events Encountered
- timeFrame
- Adverse Events were monitored until the patient's exit from the study (up to 6 months post-treatment).
- description
- Safety of the treatment was determined by evaluating the incidence of Adverse Events and Adverse Device Effects. Adverse Device Effects are Adverse Events that are related to treatment with the device. Relatedness of an Adverse Event to the treatment was determined on a case-by-case basis by the investigator. The average number of Serious Adverse Device Effects per patient and the average number of Non-Serious Adverse Device Effects per patient are reported to provide numeric outcomes of this evaluation.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Age 18-55 years * Patients seeking relief from uterine fibroid related symptoms, including those scheduled to undergo abdominal hysterectomy due to benign pathology * Patients able and willing to provide informed consent Exclusion Criteria: * Visible scar within the HIFU beam path that cannot be avoided * Known or suspected abdominal adhesions between the anterior uterine serosa and the abdominal wall * Currently pregnant or desire to become pregnant in the future * Pelvic malignancy * Pelvic congenital malformation * Acute pelvic infection * Otherwise determined by a physician to be inappropriate for the study
References
Publications (5)
- RESULTParsons JE, Lau MPH, Martin PJ, Islas Lagos JJ, Aguilar Aguirre JM, Garza Leal JG. Pilot Study of the Mirabilis System Prototype for Rapid Noninvasive Uterine Myoma Treatment Using an Ultrasound-Guided Volumetric Shell Ablation Technique. J Minim Invasive Gynecol. 2017 May-Jun;24(4):579-591. doi: 10.1016/j.jmig.2017.01.010. Epub 2017 Jan 18. PMID 28109895
- RESULTGarza Leal JG, Hernandez Leon I, Castillo Saenz L, Aguilar Aguirre JM, Islas Lagos JJ, Parsons JE, Darlington GP, and Lau MPH. In-Office Rapid Volumetric Ablation of Uterine Fibroids under Ultrasound Imaging Guidance: Preclinical and Early Clinical Experience with the Mirabilis Transabdominal HIFU Treatment System. Proceedings of the 14th International Symposium on Therapeutic Ultrasound. AIP Conference Proceedings 1821: 020001 (2017).
- RESULTGarza Leal JG, Hernandez Leon I, Castillo Saenz L, Aguilar Aguirre JM, Islas Lagos JJ, Parsons JE, Martin PM, and Lau MPH. Refinement of the Shell Ablation Technique for Rapid In-Office Treatment of Uterine Fibroids under Ultrasound Imaging Guidance using the Mirabilis Transabdominal HIFU System. 15th International Symposium on Therapeutic Ultrasound Program and Abstracts: 156 (2015).
- RESULTLau M, Aguilar Aguirre JM, Islas Lagos JJ, and Garza Leal JG. Office Based High-Speed Ultrasound Image Guided HIFU (High Intensity Focused Ultrasound) Ablation of Uterine Fibroids. Gynecol. Surg. 11 (Suppl. 1): 149-150 (2014).
- RESULTGarza Leal JG, Hernandez Leon I, Castillo Saenz L, Aguilar Aguirre JM, Islas Lagos JJ, Parsons JE, Darlington GP, and Lau MPH. In-Office Rapid Volumetric Ablation of Uterine Fibroids under Ultrasound Imaging Guidance: Preclinical and Early Clinical Experience with the Mirabilis Transabdominal HIFU Treatment System. 14th International Symposium on Therapeutic Ultrasound Program and Abstracts: 43 (2014).